rRNA扩增方法对结核分枝杆菌临床诊断作用的评估  

Evaluation of rRNA amplification assay for detection of Mycobacterium tuberculosis

作　　者：夏辉[1] 尚美[1] 刘冠[1] 李辉 王海英[3] 闫国蕊 杨红艺[3] 马晓光[3] 景辉[3] 赵雁林[1] 

机构地区：[1]北京市结核病胸部肿瘤研究所,北京101149 [2]河南疾病预防控制中心,郑州450016 [3]山东省胸科医院,济南250013

出　　处：《中国防痨杂志》2010年第9期576-580,共5页Chinese Journal of Antituberculosis

摘　　要：目的评价rRNA扩增方法在临床应用的效果。方法选取到北京胸科医院、山东省胸科医院、河南疾控中心结核病防治所3个机构就诊的肺结核可疑症状者及健康志愿者的痰标本为研究对象,共纳入551例痰标本,对每例痰标本均进行涂片显微镜检查、罗氏培养、rRNA扩增试验以及实时荧光定量PCR。与罗氏培养方法比较分析rRNA扩增方法的敏感性、特异性、阳性预测值和阴性预测值以及与实时荧光定量PCR扩增方法的一致性。结果 rRNA扩增方法的敏感性为98.5%,特异性为95.0%,阳性预测值为95.0%,阴性预测值为98.5%,rRNA扩增方法在涂阳标本和涂阴标本间的敏感度和特异度差异均有统计学意义(χ2=9.60,P=0.002;2χ=79.80,P<0.01)。与PCR检测结果的一致性为93.8%,涂阳和涂阴标本中2种方法的一致性差异有统计学意义(2χ=4.45,P=0.035)。结论 rRNA扩增方法的敏感度和特异度均较好,且能明显缩短诊断时间,该方法是一种较有前景的结核病实验室诊断方法。Objective To evaluate the clinical value of rRNA amplification assay in the detection of Mycobacterium tuberculosis. Methods 551 sputum specimens from the patients with doubtful tuberculosis and health volunteers were detected using smear microscopy,L-J medium culture,rRNA amplification assay and real-time PCR.L-J culture used as control,the sensitivity,specificity,positive predictive value and negative predictive value of rRNA assay were analyzed.The accordance rate between rRNA assay and real-time PCR was also analyzed. Results Compared with L-J culture,the sensitivity,specificity,positive predictive value and negative predictive value of rRNA assay were 98.5%,95.0%,95.0% and 98.5%,respectively.Its sensitivity and specificity had significant difference between smear-positive and smear-negative specimens(P<0.01).Accordance rate between rRNA amplification assay and real-time PCR was 93.8%,which had significant difference between smear-positive and smear-negative specimens(P<0.05). Conclusion rRNA amplification assay has a higher sensitivity and specitivity,can shorten the detection time.It would be a promising laboratory diagnosis method.

关 键 词：结核 肺/诊断 分枝杆菌 结核 rRNA扩增技术 敏感性与特异性 

分 类 号：R440[医药卫生—诊断学]